Directive 98/79 definition

Directive 98/79 means Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices(5);
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Examples of Directive 98/79 in a sentence

  • Annexes V and VII;(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and(c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

  • The Secretary of State shall perform, as respects the United Kingdom, the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to(3) of Directive 98/79.

  • Annex V and either Annex VI or Annex VII; (b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and (c) ensures that the device meets the provisions of Directive 98/79 which apply to it.

  • The aim of the package should thus be to complement rather than provide an alternative to legislative change.

  • This CE marking may be affixed to an in vitro diagnostic medical device only if it complies with the essential requirements and has been the subject of the evaluation procedures applicable to it.All of the essential requirements and conditions for compliance are described in Regulation (EU) No.2017/746 of 5 April 2017 on in vitro diagnostic medical devices repealing Directive 98/79 EC and Commission Decision 2010/227/EU.

  • The EU regulatory framework for medical devices is set out in three Directives: Directive 90/385/EEC on Active Implantable Medical Devices; Directive 93/42/EEC on Medical Devices; and Directive 98/79 /EC on In Vitro Diagnostic Medical Devices.

  • PART 3Modification of Annexes to Directive 98/79 24.—(1) The Annexes to Directive 98/79 are modified so that they read as if amended by paragraphs 25 to 33.(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.25.

  • In order to be compliant with this criterion bidder will be requested to provide one of the following pre-market approval(s) / market clearance(s)/registration(s): A.1. CE mark (EU), (Directive 93/42 EEC or Directive 98/79 EEC), orA.2. Registration No. issued by the Medicines and Medical Devices Agency of the Republic of Moldova;(A.3. is deleted) 2.1.2. B.

  • Directive 98/79 on in Vitro Diagnostic Medical DevicesThe Directive applies to in vitro diagnostic medical devices and their accessories that are treated as in vitro diagnostic medical devices in their own right.

  • The new rules replace Med Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In-Vitro Diagnostic Medical Device Directive (98/79/ EC).

Related to Directive 98/79

  • Council Directive means Council Directive 89/552/EEC of 3 October 1989 on the co-ordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities as amended by Directive 97/36/EC of the European Parliament and of the Council of 30 June 1997 and by Directive 2007/65/EC of the European Parliament and of the Council of 11 December 2007. A simplified and codified version of these Directives was introduced in 2010: the Audiovisual Media Services Directive 2010/13/EU.

  • CRD Directive means Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (as amended from time to time, including by Directive (EU) 2019/878 of the European Parliament and of the Council of 20 May 2019);

  • Waste Framework Directive or “WFD” means Waste Framework Directive 2008/98/EC of the European Parliament and of the Council on waste

  • Directive means EC Council Directive 2001/23/EC

  • Change Directive means a written order signed by the procurement officer that

  • Solvency II Directive means Directive 2009/138/EC of the European Parliament and of the Council of the European Union of 25 November 2009 on the taking-up and pursuit of the business of insurance and reinsurance (Solvency II);

  • Labor law decision means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

  • Environmental, Health or Safety Requirements of Law means all Requirements of Law derived from or relating to foreign, federal, state and local laws or regulations relating to or addressing pollution or protection of the environment, or protection of worker health or safety, including, but not limited to, the Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. § 9601 et seq., the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651 et seq., and the Resource Conservation and Recovery Act of 1976, 42 U.S.C. § 6901 et seq., in each case including any amendments thereto, any successor statutes, and any regulations or guidance promulgated thereunder, and any state or local equivalent thereof.

  • UCITS Directive means Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities, as amended;

  • Construction Change Directive means a written order prepared by Owner Parties and signed by Owner directing Contractor to perform a change in the Work prior to agreeing to a change, if any, to the Contract Time, schedule of performance of the Work, Contract Sum, or Contractor’s compensation.

  • Capital Requirements Directive means Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, as amended or replaced from time to time.

  • Industrial Emissions Directive means DIRECTIVE 2010/75/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 November 2010 on industrial emissions

  • Environmental and Social Management Framework or “ESMF” means an instrument satisfactory to the Association, prepared and adopted by the Recipient and dated February 5, 2010 outlining the process for management of the environmental and social aspects of the Project as the same may be amended from time to time with the Association’s prior written concurrence.

  • Directives means intergovernmental, interagency, or interdepartment administrative or procedural guidelines or instructions which do not affect the rights of, or procedures and practices available to, the public.

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, ordinances and other provisions having the force or effect of law, all judicial and administrative orders and determinations, all contractual obligations and all common law concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, chemical substances or mixtures, pesticides, pollutants, contaminants, toxic chemicals, petroleum products or byproducts, asbestos, polychlorinated biphenyls, noise or radiation, each as amended and as now or hereafter in effect.

  • Advance directive means a document that contains a health care instruction or a power of attorney for health care.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Environmental, Health and Safety Laws means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act of 1976, and the Occupational Safety and Health Act of 1970, each as amended, together with all other laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof) concerning pollution or protection of the environment, public health and safety, or employee health and safety, including laws relating to emissions, discharges, releases, or threatened releases of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes into ambient air, surface water, ground water, or lands or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes.

  • Environmental and Social Management Plan or “ESMP” means a site-specific environmental and social management plan to be prepared in accordance with the parameters laid down in the ESMF and acceptable to the Association, setting forth a set of mitigation, monitoring, and institutional measures to be taken during the implementation and operation of the Project activities to eliminate adverse environmental and social impacts, offset them, or reduce them to acceptable levels, and including the actions needed to implement these measures.

  • Advance health care directive means a power of attorney for health care or a record signed or authorized by a prospective donor containing the prospective donor’s direction concerning a health care decision for the prospective donor.

  • Airworthiness Directive or “AD” means any airworthiness directive issued by the Certificating Authority, in addition to any airworthiness directive issued by the Aeronautics Authority, each to the extent the same is applicable to the Aircraft and/or any Item of Equipment.

  • CRD IV Directive means Directive 2013/36/EU on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms of the European Parliament and of the Council of 26 June 2013, as the same may be amended or replaced from time to time.

  • Environmental and Safety Requirements means all federal, state, local and foreign statutes, regulations, ordinances and similar provisions having the force or effect of law, all judicial and administrative orders and determinations, all contractual obligations and all common law concerning public health and safety, worker health and safety and pollution or protection of the environment, including all such standards of conduct and bases of obligations relating to the presence, use, production, generation, handling, transport, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, chemical substances or mixtures, pesticides, pollutants, contaminants, toxic chemicals, petroleum products or by-products, asbestos, polychlorinated biphenyls (or PCBs), noise or radiation.

  • Elective Treatment and Procedures means any medical treatment or surgical procedure that is not medically necessary, including any service, treatment, or supplies that are deemed by the federal, or a state or local government authority, or by Us to be research or experimental or that is not recognized as a generally accepted medical practice.

  • Health and Safety Laws means any Laws pertaining to safety and health in the workplace, including the Occupational Safety and Health Act, 29 U.S.C. 651 et seq. (“OSHA”), and the Toxic Substances Control Act, 15 U.S.C. 2601, et seq. (“TSCA”).

  • Public Finance Management Act ’ means the Public Finance Management Act, 1999 (Act No. 1 of 1999);